Potassium iodide

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Justification for type of information:

Data is from experimental study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2014

Report date:

2014

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Principles of method if other than guideline:

The skin irritation study of test chemical was condcuted to determine the skin irritation potential of test chemical according to OECD Guideline 404 (Acute Dermal Irritation / Corrosion).

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Potassium iodide

EC Number:

231-659-4

EC Name:

Potassium iodide

Cas Number:

7681-11-0

Molecular formula:

IK

IUPAC Name:

potassium iodide

Test material form:

other: solid

Details on test material:

Identification: Potassium IodideAppearance: White SolidBatch number: Lot. 03/32CAS No.: 7681-11-0AI Content: 99.50 % Storage conditions : Room temperature (20 - 30 °C)

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
-Species:Rabbit (Oryctolagus cuniculus)
-Strain:New Zealand White
- Sex: Female
- Health Status: Healthy young adults rabbits were used for the study.Females were nulliparous and non-pregnant
- Age at study initiation: 4.5 to 5.0 Months (Approximately)
- Weight at study initiation: Minimum: 1.860 kg & Maximum: 2.458 kg (Prior to Treatment)
- Housing: The animals were housed individually in stainless steel cages
- Diet (e.g. ad libitum): All animals were provided conventional laboratory rabbit diet (Nutrivet Life Sciences) ad libitum. Batch No. 200004
- Water (e.g. ad libitum): Aqua guard filtered tap water was provided ad libitum
- Acclimation period: Rabbits were acclimatised to the test conditions for a period of 6 days (Animal No.-1) and 8 days (Animal No.-2 and 3) prior to the application of the test item
- Identification: During acclimatization marking was done with non toxic marker pen in the inside of left ear of rabbits and after acclimatization, animals were marked with permanent number in the inner side of right ear of rabbits. Permanent marker and cage card was used for identification. The individual cage cards were labelled with at least study no., study type, test system, sex, dose, experiment start date and experiment completion date.
- Room Sanitation: The experimental room floor and work tops were swept and mopped with disinfectant solution every day.
- Cages and water bottle: All the cages and water bottles were changed minimum twice a week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): Minimum: 20.30°C and Maximum: 22.70 °C
- Humidity (%): Minimum: 48.30 % and Maximum: 68.30 %
- Air changes (per hr): More than 12 changes per hour
- Photoperiod (hrs dark / hrs light): 12:12

Test system

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 ml
VEHICLE: Not applicable

Duration of treatment / exposure:

4 hours

Observation period:

1, 24, 48 and 72 hrs

Number of animals:

3

Details on study design:

TEST SITE
- Area of exposure: approximately 6 X 6 cm at contralateral sites
- Type of wrap if used: porous gauze dressing and non-irritating tape (Micropore 3”)

REMOVAL OF TEST SUBSTANCE
- Washing (if done): residual test item was removed by using cotton soaked in distilled water
- Time after start of exposure: 4hr

Control site: 0.5 ml distilled water was applied at control site.

SCORING SYSTEM: Draize Method

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: Not applicable

Remarks on result:

no indication of irritation

Results 2

Irritation parameter:

edema score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: Not applicable

Remarks on result:

no indication of irritation

Irritant / corrosive response data:

No erythema and edema (skin irritation) were observed at the end of 72 hour observation period after patch removal.

Other effects:

no effects observed

Any other information on results incl. tables

Table 1

Skin Reaction

 

In Treated area Dose:0.5 g (Pulverized form)                                                     Sex:Female

 

Animal No.	Test	Treated  area	Erythema score				Oedema score
			1h	24h	48h	72h	1h	24h	48h	72h
1	Initial	Right	1	1	0	0	0	0	0	0
2	Confirmatory	Left	0	0	0	0	0	0	0	0
3		Left	1	0	0	0	0	0	0	0

 In Control areaDose:0.5 ml of distilled water                                                   Sex:Female

 

Animal No.	Test	Treated area	Erythema score				Oedema score
			1h	24h	48h	72h	1h	24h	48h	72h
1	Initial	Left	0	0	0	0	0	0	0	0
2	Confirmatory	Right	0	0	0	0	0	0	0	0
3		Right	0	0	0	0	0	0	0	0

Key: h = Hour.

Erythema                                                                                                       Oedema

0 =No erythema                                                                                           0 =No oedema

1 = Very slight erythema(barely perceptible)

Table 1 Continued…

Mean Individual Animal Score at 24, 48 and 72 hours (Treated Site)

 

Animal Number                   Observations	1	2	3
Erythema	0.33	0.00	0.00
Oedema	0.00	0.00	0.00

 

Applicant's summary and conclusion

Interpretation of results:

other: not irritating

Conclusions:

The individual mean score at 24, 48 and 72 hours for Animal Nos. 1, 2 and 3 were 0.33, 0.00, 0.00 and 0.00, 0.00, 0.00, for erythema and oedema formation, respectively. No erythema and no edema (skin irritation) were observed at 72 hours observation period after patch removal.
Hence, it was concluded that the test substance was Non-Irritating to the skin of female New Zealand White rabbits under the experimental conditions tested and being classified as “Not Classified” as per CLP Classification.

Executive summary:

Acute Dermal Irritation/corrosion Study of test chemical in Rabbits, was performed as per OECD guideline No. 404.  Three healthy young adult female New Zealand White rabbits were used for conducting acute dermal irritation/corrosion study. Body weights were recorded on day 0 (prior to application) and at termination. Rabbits with good intact skin were selected for the study. The hairs of all the rabbits were clipped at contralateral sites, approximately 24 hours prior to treatment. A dose of 0.5 ml of test item (as such) was applied to the skin, over an area of approximately 6 x 6 cm clipped of hair on one side of rabbits. The other untreated side was kept as control area and 0.5 ml of distilled water was applied at this site. At the end of 4 hours, the gauze patch was removed and test item application site was wiped with water without altering the integrity of the epidermis.

Initially, the test item was applied to the clipped area of skin of one rabbit. The test site was covered with gauze patch. Very slight erythema (barely perceptible) and no edema was observed at 1 hour of observation. At 24 hour very slight erythema (barely perceptible) and no edema was observed. At 48 and 72 hours observation no erythema and no edema was observed in animal no 1.Hence the confirmatory test was conducted on additional two rabbits (no. 2 and 3) to confirm the non-irritant nature of the test item.

The patch was removed after 4 hours and rabbits were observed for erythema and oedema at 1, 24, and 48 and 72 hours after patch removal, evaluated and graded as per Draize method. In animal no 3, at 1 hour observation post patch removal, reveled very slight erythema (barely perceptible) and no edema whereas Animal No.2 showed no erythema and edema. At 24, 48 and 72 hours, animal nos. 2 and 3 showed no erythema and no oedema.

The individual mean score at 24, 48 and 72 hours for Animal Nos. 1, 2 and 3 were 0.33, 0.00, 0.00 and 0.00, 0.00, 0.00, for erythema and oedema formation, respectively.No erythema and no edema (skin irritation) were observed at 72 hours observation period after patch removal.

Hence, it was concluded that the test substance was Non-Irritating to the skin of female New Zealand White rabbits under the experimental conditions tested and being classified as “Not Classified” as per CLP Classification.